Determining the effect of using low power laser on the amount of lateral movements of the jaw after orthognathic surgery
Design
This study is a clinical trial with a control group, with parallel, double-blind, randomized groups on 12 patients who are candidates for orthognathic surgery. The study will be in the form of a split mouth. Random number table was used for randomization.
Settings and conduct
12 patients who are candidates for orthodontic surgery of the jaw are selected for the study. On a daily basis in 4 times immediately after surgery, two days later, four days later and one week after laser surgery. Low power with an output power of 50 mW and a dose of 5 joules per square centimeter is irradiated at the site of laser surgical incisions
Participants/Inclusion and exclusion criteria
1. Patient age (between 18 and 40 years)
3. Absence of systemic diseases
4. Do not use tobacco
5. Do not take drugs that affect healing.
6. Patients' surgery is performed by a surgeon.
7. Absence of systemic diseases or use of drugs effective in wound healing
8. No history of seizures Pregnancy thyroid tumors Malignant oral tumors for laser treatment
9. The disease does not have asymmetry
Intervention groups
Lefort 1 maxillary and bilateral sagittal split (BSSO) ostomy will be performed for all patients. The low power laser used is the 660 nm low power laser. In 12 patients, 6 of them are on the right side for laser treatment and the left side is off. In the remaining 6 patients, the left side is off for laser treatment and the right side is off.
Main outcome variables
Trismus and the amount of lateral movements of the jaw
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180312039060N4
Registration date:2020-11-28, 1399/09/08
Registration timing:prospective
Last update:2020-11-28, 1399/09/08
Update count:0
Registration date
2020-11-28, 1399/09/08
Registrant information
Name
Alireza Ebrahimpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 4326 0653
Email address
alireza.ebrahimpour.1996@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-09, 1399/09/19
Expected recruitment end date
2021-04-17, 1400/01/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of660nm low level laser therapy on level of jaw’s lateral movement after orthognathic surgery
Public title
Effect of laser therapy on level of jaw’s movement after orthognathic surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Absence of systemic diseases
No smoking
Do not take drugs that affect healing
Patients' surgery is performed by a surgeon.
Absence of systemic diseases, use of drugs effective in wound healing
No history of seizures Pregnancy thyroid tumors Malignant oral tumors for laser treatment
Do not have asymmetric disease
Age range 18-40 years
Exclusion criteria:
The patient's unwillingness to cooperate in the study
Infection after surgery
Sensitivity or allergies
In case of unwanted accidents during the operation, such as bad fracture
If you need genioplasty with bimax operation (two jaws)
Age
From 18 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
12
Randomization (investigator's opinion)
Randomized
Randomization description
Samples were numbered from 1 to 12. Randomization was performed with the help of true random generator software at random.org. In this way, in the software, a minimum of 1 and a maximum of 12 were assumed. Then 6 distinct and non-duplicate numbers were taken from the software and the numbers were classified in the first group and other samples in the second group.
Blinding (investigator's opinion)
Double blinded
Blinding description
In 12 patients, 6 of them are on the right side for laser treatment and the left side is off. In the remaining 6 patients, the left side is off for laser treatment and the right side is off.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University Isfahan (Khorasgan) Branch
Street address
Esfahan - East Gey Street - Arghavanieh-Ethics committee of Islamic Azad University Isfahan (Khorasgan) Branch-
City
Khorasgan
Province
Isfehan
Postal code
4361043610
Approval date
2019-03-12, 1397/12/21
Ethics committee reference number
IR.IAU.KHUISF.REC.1398.006
Health conditions studied
1
Description of health condition studied
Trismus and the amount of lateral movements of the jaw
ICD-10 code
S02
ICD-10 code description
Fracture of skull and facial bones
Primary outcomes
1
Description
Trismus
Timepoint
Immediately after surgery, two days later, four days later and one week after surgery
Method of measurement
Using a ruler, the maximum opening of the patient's mouth is recorded and compared in the stated time periods.
2
Description
The amount of lateral movements of the jaw
Timepoint
Immediately after surgery, two days later, four days later and one week after surgery
Method of measurement
To evaluate postoperative trismus in patients, two days and seven days after surgery, we measure the lateral movements of the jaw to the right and the lateral movements of the left jaw to mm, and the deviation of the jaw when opening the mouth on the second, seventh days. And the fourteenth is measured
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 12 patients are randomly divided into two groups of 6, in the first group laser treatment is performed on the right side of the face and in the second group on the left side for laser treatment.
Category
Rehabilitation
2
Description
Control group: In the first group, the left side of the mouth will be used as a control, and the laser will be pretended to shine while it is off. In the second group, this action will be done on the right side of the mouth
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani hospital
Full name of responsible person
Alireza Sadighi
Street address
Esfahan - East Gey Street - Arghavanieh-Ethics committee of Islamic Azad University Isfahan (Khorasgan) Branch-
City
isfahan
Province
Isfehan
Postal code
4613646136
Phone
+98 31 3535 4053
Email
arsadighi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Shapour Haj rasouliha
Street address
Esfahan - East Gey Street - Arghavanieh-Ethics committee of Islamic Azad University Isfahan (Khorasgan) Branch-
City
Isfahan
Province
Isfehan
Postal code
۸۱۵۵۱-۳۹۹۹۸
Phone
+98 31 3535 4053
Email
info@khuisf.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Alireza Sadighi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Esfahan - East Gey Street - Arghavanieh-Ethics committee of Islamic Azad University Isfahan (Khorasgan) Branch-
City
Esfahan
Province
Isfehan
Postal code
۸۱۵۵۱۳۹۹۹۸
Phone
+98 31 3535 4053
Email
arsadighi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Alireza Sadighi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Esfahan - East Gey Street - Arghavanieh-Ethics committee of Islamic Azad University Isfahan (Khorasgan) Branch-
City
Esfahan
Province
Isfehan
Postal code
۸۱۵۵۱۳۹۹۹۸
Phone
+98 31 3535 4053
Email
arsadighi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Alireza Ebrahimpour
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
blv Khazar, faculty of Dentistry
City
Sari
Province
Mazandaran
Postal code
12345-56987
Phone
+98 11 3355 6698
Email
alireza.ebrahimpour.1996@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
all data
When the data will become available and for how long
after paper published
To whom data/document is available
all person
Under which criteria data/document could be used
no situation
From where data/document is obtainable
alireza sadigh 09143083724
What processes are involved for a request to access data/document